Aliskiren Hemifumarate, Amlodipine Besylate Oral tablet

What is this medicine?

ALISKIREN; AMLODIPINE (a lis KYE ren; am LOE di peen) is a combination of a renin inhibitor and a calcium channel blocker. This medicine is used to treat high blood pressure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• dehydration

• diabetes

• heart problems like heart failure or aortic stenosis

• kidney disease

• liver disease

• an unusual or allergic reaction to aliskiren, amlodipine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on your prescription label. You may take this medicine with or without food, but try to take it the same way every time. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• atorvastatin

• certain medicines for fungal infections like ketoconazole and itraconazole

• cyclosporine

• diuretics

• medicines for blood pressure

• potassium supplements

• salt substitutes with potassium

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Check your blood pressure as directed. Ask your doctor or health care professional what your blood pressure should be and when you should contact him or her.

If you have diabetes and are taking a medicine called an angiotensin-receptor-blocker (ARB) or angiotensin-converting-enzyme-inhibitor (ACE inhibitor), do not take this medicine. Talk to your doctor or health care professional for more information.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

This medicine may make you feel confused, dizzy or lightheaded. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce the risk of dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Avoid alcoholic drinks; they can make you more dizzy.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or hives, swelling of the hands, feet, face, lips, throat, or tongue

• breathing problems

• chest pain

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• low blood pressure

• seizures

• swelling of ankles, feet, hands

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• cough

• diarrhea

• dry mouth

• facial flushing

• nausea, vomiting

• upset stomach

• weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from heat and moisture. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.